U.S. patent number 6,245,360 [Application Number 09/340,106] was granted by the patent office on 2001-06-12 for nutritional supplement.
Invention is credited to John S. Markowitz.
United States Patent |
6,245,360 |
Markowitz |
June 12, 2001 |
Nutritional supplement
Abstract
A single entity product is provided for administration to
persons being treated for nutritional deficiencies associated with
addiction to alcohol, wherein the product is an extended-release
multivitamin with minerals and trace elements in beneficial dose
ranges and specifically contains thiamine and folic acid in the
desired amounts of about 100 mg and 1 mg, respectively. The product
may also contain riboflavin in an amount between about 1 mg and
about 3 mg, pyridoxine in an amount between about 1 mg and about 3
mg, cyanocobalamin in an amount between about 6 mg and about 12 mg,
biotin in an amount between about 10 mcg and about 50 mcg, niacin
in an amount between about 10 mg and about 50 mg, vitamin D in an
amount between about 200 IU and about 500 IU, vitamin E in an
amount between about 10 IU and about 50 IU, selenium in an amount
between about 5 mcg and about 50 mcg, and/or magnesium in an amount
between about 100 mg and about 400 mg.
Inventors: |
Markowitz; John S. (Mt.
Pleasant, SC) |
Family
ID: |
26782743 |
Appl.
No.: |
09/340,106 |
Filed: |
June 25, 1999 |
Current U.S.
Class: |
424/641; 424/464;
424/468; 424/643; 424/646; 424/682; 424/702; 426/72; 426/73;
426/74; 514/167; 514/168; 514/248; 514/251; 514/276; 514/315;
514/345; 514/356; 514/387; 514/458; 514/474; 514/492; 514/494;
514/502; 514/52; 514/724; 514/810; 514/811; 514/904; 514/905;
514/964 |
Current CPC
Class: |
A23L
33/15 (20160801); A23L 33/16 (20160801); Y10S
514/81 (20130101); Y10S 514/811 (20130101); Y10S
514/964 (20130101); Y10S 514/904 (20130101); Y10S
514/905 (20130101) |
Current International
Class: |
A23L
1/302 (20060101); A23L 1/304 (20060101); A61K
033/00 (); A61K 009/20 (); A61K 031/00 () |
Field of
Search: |
;424/464,468,641,643,646,682,702 ;426/72,73,74
;514/52,167,168,248,251,276,315,252,295,345,356,387,458,474,492,494,502,724,810 |
References Cited
[Referenced By]
U.S. Patent Documents
Other References
Markowitz et al., "Savings on Nutritional Supplements Administered
to Patients with Chronic Alcoholism," Am J Health-Syst Pharm , vol.
53, p. 1336, Jun. 1996..
|
Primary Examiner: Dees; Jose' G.
Assistant Examiner: Choi; Frank
Attorney, Agent or Firm: Kenyon & Kenyon
Parent Case Text
This application claims the benefit of provisional No. 60/090,883
filed Jun. 26, 1998.
Claims
What is claimed is:
1. A nutritional supplement for administration to persons being
treated for nutritional deficiencies associated with addiction to
alcohol, the nutritional supplement consisting of a single
extended-release pill, wherein the single extended-release pill
comprises the following components:
vitamin A in an amount of about 5,000 IU;
vitamin C in an amount of about 500 mg;
thiamine in an amount of about 100 mg;
riboflavin in an amount of about 3 mg;
pyridoxine in an amount of about 3 mg;
cyanocobalamin in an amount of about 12 mg;
niacin in an amount of about 20 mg;
vitamin D in an amount of about 400 IU;
vitamin E in an amount of about 30 IU;
folic acid in an amount of about 1 mg;
biotin in an amount of about 30 mcg;
calcium in an amount of about 250 mg;
iron in an amount of about 60 mg;
magnesium in an amount of about 200 mg;
zinc in an amount of about 4 mg; and
selenium in an amount of about 10 mcg.
2. A nutritional supplement for administration to persons being
treated for nutritional deficiencies associated with addiction to
alcohol, the nutritional supplement consisting of a single pill,
wherein the single pill comprises the following components:
vitamin A;
vitamin C;
thiamine in an amount between about 50 mg and about 100 mg;
riboflavin in an amount between about 1 mg and about 3 mg;
pyridoxine in an amount between about 1 mg and about 3 mg;
cyanocobalamin in an amount between about 6 mg and about 12 mg;
niacin in an amount between about 10 mg and about 50 mg;
vitamin D in an amount between about 200 IU and about 500 IU;
vitamin E in an amount between about 10 IU and about 50 IU;
folic acid in an amount of about 1 mg;
biotin in an amount between about 10 mcg and about 50 mcg;
calcium;
iron;
magnesium in an amount between about 100 mg and about 400 mg;
zinc; and
selenium in an amount between about 5 mcg and about 50 mcg.
3. The nutritional supplement according to claim 2, wherein the
thiamine component in the single pill is in an amount of about 100
mg.
4. A nutritional supplement for administration to persons being
treated for nutritional deficiencies associated with addiction to
alcohol, the nutritional supplement consisting of a single pill,
wherein the single pill comprises the following components:
thiamine in an amount between about 50 mg and about 100 mg;
folic acid in an amount of about 1 mg;
riboflavin in an amount between about 1 mg and about 3 mg;
pyridoxine in an amount between about 1 mg and about 3 mg;
cyanocobalamin in an amount between about 6 mg and about 12 mg;
biotin in an amount between about 10 mcg and about 50 mcg;
niacin in an amount between about 10 mg and about 50 mg;
vitamin D in an amount between about 200 IU and about 500 IU;
and
vitamin E in an amount between about 10 IU and about 50 IU.
5. The nutritional supplement according to claim 4, wherein the
thiamine component in the single pill is in an amount of about 100
mg.
6. The nutritional supplement according to claim 4, wherein the
single pill further comprises the following components:
vitamin A; and
vitamin C.
7. The nutritional supplement according to claim 6, wherein the
thiamine component in the single pill is in an amount of about 100
mg.
8. The nutritional supplement according to claim 6, wherein the
single pill further comprises the following components:
selenium in an amount between about 5 mcg and about 50 mcg; and
magnesium in an amount between about 100 mg and about 400 mg.
9. The nutritional supplement according to claim 8, wherein the
thiamine component in the single pill is in an amount of about 100
mg.
10. The nutritional supplement according to claim 8, wherein the
single pill further comprises the following components:
calcium;
iron; and
zinc.
11. The nutritional supplement according to claim 10, wherein the
thiamine component in the single pill is in an amount of about 100
mg.
12. The nutritional supplement according to claim 4, wherein the
single pill further comprises the following components:
selenium in an amount between about 5 mcg and about 50 mcg; and
magnesium in an amount between about 100 mg and about 400 mg.
13. The nutritional supplement according to claim 12, wherein the
thiamine component in the single pill is in an amount of about 100
mg.
14. The nutritional supplement according to claim 12, wherein the
single pill further comprises the following components:
calcium;
iron; and
zinc.
15. The nutritional supplement according to claim 14, wherein the
thiamine component in the single pill is in an amount of about 100
mg.
16. The nutritional supplement according to claim 4, wherein the
pill is an extended-release pill.
Description
FIELD OF THE INVENTION
This invention relates to vitamin and mineral supplements
specifically formulated to target the nutrient deficits commonly
encountered in malnourished alcoholic patients during their
recovery.
BACKGROUND OF THE INVENTION
Each year, approximately 1.5 million Americans seek
medical/psychiatric treatment for alcoholism. Alcoholism remains
one of the major causes of nutritional deficiency syndromes in the
United States. Alcohol (ethanol) is directly toxic to many tissues
and can affect almost every cell and organ system in the human
body. Additionally, chronic use leads to impaired absorption,
transport, and storage of numerous vitamins and minerals (Persson
J., Scandinavian Journal of Gastroenterology, 1991;26: pp. 3-15.).
Further, the nutritional content of ethanol is very poor and is
often consumed in the context of inadequate dietary intake. For
example, on average Americans consume about 4.5% of total calories
as alcohol while alcoholics may consume 50% of their daily calories
as ethanol (Feinman L., Lieber C. S. in: Medical and Nutritional
Complications of Alcoholism: Mechanisms of Management. (Ed. Lieber,
C. S.), 1992 Plenum Medical Book Company, New York, pp. 515-530.).
The exact reasons for poor food intake among alcoholics are unknown
but may include depressed consciousness during intoxication,
hangover, and gastrointestinal problems induced by ethanol
consumption.
Vitamins
Serious medical complications may occur as a result of uncorrected
malnutrition. Most notably, as a result of thiamine (Vitamin
B.sub.1) deficiency, Wernicke's syndrome, an encephalopathy marked
by gait disturbance, acute confusion, memory loss and
disorientation may develop in chronic users of ethanol. If
untreated with thiamine supplementation, this condition may
progress to the more serious Korsakoffs syndrome, a permanent
disorder leading to brain damage in which patients manifest
symptoms such as psychosis, severe memory loss, delirium, insomnia,
and painful extremities. These patients frequently require
long-term institutionalization. Additionally, beriberi heart
disease and possibly polyneuropathy may result from thiamine
deficiency. Alcoholics have demonstrated impaired abilities to
absorb thiamine (Holzbach E. Journal of Studies on Alcohol,
1996;57: pp. 581-584.). However, it is clinically impractical to
measure thiamine blood concentrations. Thiamine corrects early
Wernicke signs rapidly and may prevent development of an
irreversible Korsakoff dementia. Once the dementia is established,
thiamine usually does not help. Therefore, due to the relative
safety and ease of administering thiamine, 50-100 mg is generally
given orally as a separate drug entity to [all] alcoholics daily
while in treatment.
A significant number of alcoholics suffer from anemia, a general
term for describing a reduction in the number of circulating red
blood cells (erythrocytes). The clinical expression of anemia
results from tissue hypoxia or oxygen starvation and the resulting
cardiovascular pulmonary compensatory responses. Severe anemia is
associated with weakness, vertigo, headache, tinnitus, fatigue,
drowsiness, irritability, and in some cases bizarre behavior.
Additionally, amenorrhea, loss of libido, GI complaints, and
splenomegaly can result. Finally, heart failure and shock may
result in some patients. Specifically, megaloblastic anemia, a
disorder in the body's ability to manufacture functional red blood
cells (erythropoiesis) may occur in a large number of alcoholics as
a result of depleted B-complex vitamins such as folic acid and/or
cyanocobalamin (Vitamin B.sub.12). Alcoholics tend to have low
folic acid status when they are drinking. Ethanol is also known to
accelerate the production of megaloblastic anemia in patients with
depleted folic acid stores. In addition to folic acid deficiency,
the direct effect of ethanol on bone marrow, liver disease,
bleeding, iron deficiency, and infection may exert additive
influences on the hematological status of the alcoholic. For this
reason, chronic ethanol users are commonly administered 1 mg of
folic acid by mouth daily as a separate drug entity while in
treatment to replete folic acid stores.
When there is a general poor intake of B-vitamins, riboflavin
(Vitamin B.sub.2) deficiency may result, and this has been found to
be the case with alcoholics (Cook C. C. H, Thomson A. D. British
Journal of Hospital Medicine, 1997;57: pp.461-465.). Clinical
consequences of riboflavin deficiency include behavioral changes
and peripheral neuropathy. For this reason, riboflavin is commonly
administered to alcoholics daily as a component (1-3 mg) of a
multivitamin as long as they are in treatment.
Behavioral changes, neurological disorders, peripheral neuropathy
and dermatological disorders can result in part due to pyridoxine
(Vitamin B.sub.6) deficiency disorders. This is most important with
regard to alcoholics since up to 50% may have pyridoxine
deficiencies as measured in plasma. It is unknown if inadequate
dietary intake alone accounts for the deficiency, but increased
destruction and reduced formation of pyridoxine may be related to
ethanol use. Whatever the cause, clinical management usually
involves provision of pyridoxine (1-3 mg) as part of a daily
multivitamin administered as long as the patient is in
treatment.
The absorption of cyanocobalamin (Vitamin B.sub.12) has also been
shown to be decreased when coadministered with ethanol.
Deficiencies may result in hematological as well as neurological
disorders. Cyanocobalamin (6-12 mg) is commonly administered as
part of a multivitamin supplement on a daily basis to alcoholics in
treatment.
Biotin is a coenzyme that is essential to the metabolism of both
fatty acids and carbohydrates. Deficiency states may result in
dermatological disorders. Biotin 10-50 mcg is commonly included in
multivitamin supplements used in the treatment of malnourished
individuals.
Niacin (Nicotinic acid) deficiency may develop as a result of poor
dietary intake among alcoholics. This water soluble vitamin is
found in many of the same foods which contain thiamine. Severe
niacin deficiency may result in the clinical condition of Pellagra
which is characterized by dermatologic, central nervous system, and
gastrointestinal symptoms. Niacin is generally included as part of
a multivitamin preparation in doses of 10-50 mg given daily.
Clearly, alcoholics have illness related to abnormalities of
vitamin D (cholecalciferol) and calcium. They have decreases in
bone density and bone mass and increased susceptibility to bone
fractures. Decreased blood calcium, phosphorous, magnesium and
25-OH-vitamin D have been reported. Changes in vitamin D metabolism
may result from the inability of the alcoholic to hydroxylate
vitamin D3 at the 25 position to its more active form. This
condition may be in part due to poor liver function, decreased
exposure to sunlight, a diet deficient in vitamin D, and
malabsorption of fat. The end result may be osteomalacia leading to
bone pain and fractures. Since poor dietary intake is common in
alcoholics, vitamin D 200-500 IU administered as part of a
multivitamin on a daily basis may be prudent.
Vitamin E and selenium serve protective roles as antioxidants and
function synergistically in the human body. For instance, vitamin E
reduces selenium requirements, prevents its loss from the body, and
maintains it in its active form. Conversely, selenium spares
vitamin E and reduces the requirement for the vitamin. Alcoholic
patients and patients with poor fat absorption may become deficient
in vitamin E. Clinical manifestations of vitamin E deficiency
include decreased erythrocyte survival, and neurological
disturbances including visual problems. Vitamin E 10-50 IU as a
component of multivitamin supplements should be administered
daily.
Trace Elements
There are 13 trace elements presently recognized as necessary for
normal biological functioning of the human body. They are referred
to as trace elements as they occur in concentrations <0.005%
body weight. In order of demonstrated need they are iron, iodine,
copper, manganese, zinc, cobalt, molybdenum, selenium, chromium,
fluorine, silicon, nickel, and arsenic (The Merck Manual, 15th
Edition (1987) pp. 894-1013). Importantly, a variety of essential
trace elements such as magnesium, zinc, and selenium are often
found in inadequate amounts in chronic alcoholics (Cook C. C. H.,
Walden R. J., Graham B. R., Gillham C., Davies S., Prichard B. N.
C. Alcohol & Alcoholism, 1991;26: pp. 541-548.).
Serum selenium levels have been found to be decreased in the
alcoholic, especially in the presence of liver disease. Selenium
should be supplemented if patients are suspected to be deficient in
this element. Muscle pain and tenderness have been reported to
result from deficiency states. Selenium may be administered at
doses from 5-50 mcg daily. However, at present, no U.S. Recommended
Daily Allowance (RDA) has been established.
Chronic alcoholism is clearly associated with magnesium deficiency
as measured by serum levels of the element. Alcohol ingestion is
known to cause magnesium excretion. Magnesium deficiency may lead
to hypocalcemia and hypoparathyroidism and clinical manifestations
may include lethargy, weakness, anorexia nausea. If magnesium
deficiency is suspected or confirmed, repletion is indicated. This
may be done by giving the element intramuscularly or by oral
supplementation. Magnesiun 100-400 mg may be given orally as a
supplement daily.
As a consequence of the known risk of malnutrition in this patient
population, most physicians who treat alcoholic patients in the
inpatient hospital settings tend to treat alcoholics with three (3)
immediate release oral supplement products, a multivitamin,
thiamine 100 mg, and folic acid 1 mg. Additionally, some patients
are also treated with thiamine and magnesium sulfate
intramuscularly on admission.
At present there is no existing single entity product to administer
to patients which is an extended-release multivitamin with minerals
and trace elements in the aforementioned dose ranges and which
specifically contains thiamine and folic acid in the desired
amounts of 100 mg and 1 mg, respectively. Umbdenstock (U.S. Pat.
No. 5,308,627) described a nutritional product to assist persons
recovering from addictions to various health damaging substances.
The product did not have folic acid in the appropriate amount (1
mg), and 3 tablets would have to be administered to approach 100 mg
of thiamine. Additionally, the Umbdenstock product contains
valerian, an herbal product of questionable utility, sedating
effects, and unlikely to be recommended by most physicians treating
alcoholic patients. Lastly, the product was not an extended release
formulation.
SUMMARY OF THE INVENTION
An object of the present invention is to provide a single entity
product to administer to patients which is an extended-release
multivitamin with minerals and trace elements in beneficial dose
ranges and which specifically contains thiamine and folic acid in
the desired amounts of 100 mg and 1 mg, respectively. The product
may be in the form of a pill, wherein the term "pill" herein is
used to include both tablets and capsules.
Inherent advantages of administering a single product rather than
three separate entities are increased patient compliance, decreased
cost through decreased nursing staff time to administer one agent
rather than three, and decreased pharmacy cost in acquisition,
inventory, and dispensing time related to a single agent compared
to three agents. Additionally, the potential for medication
administration errors would be reduced. A further advantage would
be the administration of a fewer number of pills to a population
who often have an over-reliance or concomitant dependence issues
with medications in addition to their alcoholism. Finally, an
extended-release product will allow for greater absorption of the
included water soluble vitamins (C, B.sub.2, B.sub.6, B.sub.12),
which, unlike fat soluble vitamins (A, D, E, K), are rapidly
excreted from the body following oral supplementation.
The nutritional supplemental needs of chronic alcohol users include
Vitamins A, C, B.sub.1, B.sub.2, B.sub.6, B.sub.12, D, E, Niacin,
Folic acid, and biotin (see Table 1). Mineral and trace element
deficiencies identified in alcoholics include calcium, iron,
magnesium, zinc, and selenium. These deficiencies, if uncorrected,
may result in a variety of adverse physical and psychiatric effects
as described above. The nutritional components of this invention
provide the appropriate substances in sufficient amounts to
replenish the malnourished individual. By supplying the correct
amounts of each supplement within a single entity, the present
invention simplifies treatment by avoiding the inconvenience,
potential for error, and cost of administering multiple nutritional
supplements to an individual patient. Additionally, the
extended-release formulation of the invention allows for
enhancement of absorption of water soluble vitamins compared to
available immediate-release products.
DETAILED DESCRIPTION
As an example of a nutritional supplement according to the
invention, an extended release pill may be provided which contains
the following components:
TABLE I Vitamins Vitamin A 5000 I.U. Vitamin C (Ascorbic acid) 500
mg Vitamin B.sub.1 (Thiamine) 100 mg Vitamin B.sub.2 (Riboflavin) 3
mg Vitamin B.sub.6 (Pyridoxine) 3 mg Vitamin B.sub.12
(Cyanocobalamin) 12 mg Niacin (Niacinamide) 20 mg Vitamin D
(Cholecalciferol) 400 I.U. Vitamin E (dl-alpha-Tocopherly Acetate)
30 I.U. Folic Acid 1 mg Biotin 30 mcg Minerals Calcium 250 mg Iron
(Ferrous fumerate) 60 mg Magnesium (Magnesium Oxide) 200 mg Zinc
(Zinc Sulfate) 4 mg Selenium 10 mcg
As examples of possible variations, the following components may be
supplied within the ranges given below:
thiamine in an amount between about 50 mg and about 100 mg;
riboflavin in an amount between about 1 mg and about 3 mg;
pyridoxine in an amount between about 1 mg and about 3 mg;
cyanocobalamin in an amount between about 6 mg and about 12 mg;
biotin in an amount between about 10 mcg and about 50 mcg;
niacin in an amount between about 10 mg and about 50 mg;
vitamin D in an amount between about 200 IU and about 500 IU;
vitamin E in an amount between about 10 IU and about 50 IU;
selenium in an amount between about 5 mcg and about 50 mcg; and
magnesium in an amount between about 100 mg and about 400 mg.
Persons of ordinary skill in the art will recognize that certain
variations of the above formulation may be made without departing
from the scope of the invention, as defined by the claims.
* * * * *